ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K043197

Substantially Equivalent

Lifescan, Inc.

FDA 510(k) clearance K043197 for ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2005-05-20. Applicant: Lifescan, Inc..

Clearance details

Applicant: Lifescan, Inc.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2004-11-18
Decision date: 2005-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

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Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.